Clinical trial · Interventional
Chidamide in Combination With Carboplatin and Paclitaxel in Advanced Non-small Cell Lung Cancer
A Phase II Study of Chidamide or Placebo in Combination With Carboplatin and Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer
NCT01836679CI-TRIAL-00020732completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the efficacy and safety of Chidamide combined with paclitaxel and carboplatin in patients with advanced non-small-cell lung cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small-cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Chidamide | Drug | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.The chemotherapy cycles are repeated every 3 weeks to a maximum of 4 cycles. Patients also receive Chidamide 20mg orally twice a week until disease progression,or unacceptable toxicities,or withdrawal of consent occurred.
- interventionNames
- Drug: Chidamide
- Drug: Paclitaxel
- Drug: Carboplatin
- type
- PLACEBO_COMPARATOR
- label
- Arm 2
- description
- Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.The chemotherapy cycles are repeated every 3 weeks to a maximum of 4 cycles. Patients also receive placebo orally twice a week until disease progression,or unacceptable toxicities,or withdrawal of consent occurred.
- interventionNames
- Drug: Paclitaxel
- Drug: Carboplatin
- Drug: Placebo
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histology or cytology confirmed non-small-cell lung cancer,stage IIIb or IV. Newly diagnosed or relapsed after surgery but have not received systemic drug therapy.Adjuvant chemotherapy after surgery should have completed for more than one year at study entry. * Aged 18\~75 years * Epidermal growth factor receptor (EGFR) mutation negative or EGFR status is unknown * With at least one measurable lesion * White blood cell count≥4×10\^9/L,platelet count≥100×10\^9/L and hemoglobin≥11g/L * Life expectancy \>3 months * Eastern Cooperative Oncology Group performance status of ≤1 at study entry * Women of childbearing age should have pregnancy test negative and would like to conduct birth control during the study * Have signed informed consent Exclusion Criteria: * Patients with clinically significant corrected QT interval prolongation, or ventricular tachycardia,or auricular fibrillation, or ≥Grade 2 sino-auricular heart-block,or ≥Grade 3 atrioventricular block,or myocardial infarction within one year, or congestive heart failure,or patients with symptomatic coronary disease which need to be treated by drug * The size of fluid area detected by cardiac ultrasonography in cavum pericardium is ≥10mm during diastolic period * Organ transplant patients * Patients with active bleeding or new thrombotic diseases * Patients with body temperature \>38.5℃ for more than 3 days * Total bilirubin \>1.5 fold of upper limit of normal (ULN), ALT/AST\>1.5 fold of ULN or serum creatine \>1.5 fold of ULN * Patients with symptomatic brain-metastasis * Pregnant or lactating women * Patients with mental disorder
References
Publications (0)
Data not yet available
No reference posted for this study.